I heard a rumor of someone in the Bay area claiming to work in the intelligence community, to be terminally ill, and to have received an experimental COVID-19 vaccine. I think this rumor is false with respect to the specific person, but do note that “military officers with preexisting terminal illnesses who volunteer” is a group that may actually exist, and that at least one drug company claims to have shipped vaccines for a phase 1 trial on Feb 24.
This raises the question: if you’re well resourced, desperate, competent, and in possession of expendable military volunteers, how long does development for a vaccine actually take?
Given a candidate vaccine, you need to do three things: find out if confers immunity (and how much immunity), find out if it causes side effects severe enough to not be worth it, and scale up production.
All three of these can be done in parallel. If you have expendable volunteers, you don’t need to start with an animal model; you can just give them the vaccine, and see whether they suffer side effects. Testing efficacy can be done in parallel, with the same volunteers, and takes about three weeks—you give the vaccine, wait a week, expose to virus, then wait in quarantine for two weeks.
If you’re unlucky, this kills all the test subjects. If you’re average-lucky, your test subjects get COVID-19 and die at the same rate as people die of that. If you’re lucky, you have solid evidence of effectiveness and moderate evidence of safety. Not as much evidence of safety as you want, and certainly not up to the FDA’s traditional standards, but good enough that medical workers in affected areas would seriously consider it.
Maybe it’s optimistic, but in my model of the world, there are islands of competence within the intelligence community which do things like this. In most worlds, this project fails, and the public never hears about it. The President, on the other hand, does hear about it. He hears about many vaccine projects with different timelines and different chances of success, and they all blend together. He says on the news that a vaccine will be ready in several weeks, and everyone—the NIAID, the press, the public—mocks him for the mistake, because they don’t know about the secret trial. Or maybe he never heard of anything like that, and is just confused; this is not something we are likely to ever know.
Coronavirus could spread unabated, or it could be killed by quarantines, or it could spread but lose its lethality to a new treatment, or we could be surprised by an unprecedentedly fast vaccine. Let us retain our flexibility, and keep our prediction confidence intervals wide.
Maybe it’s optimistic, but in my model of the world, there are islands of competence within the intelligence community which do things like this.
For me, that fits my model of what the US intelligence agencies used to do during the cold war times, and we have unclassified documents about proactive, unethical experimentation they did—like Operation Sea Spray and MK Ultra. I don’t know if the 2020 US intelligence community is up to the same task. I get the impression that capability and competence have fallen there, although it’s hard to know since so much is classified. But judging by the fact that we have had several elections disrupted by pretty predictable cyberattacks without visible countermeasures, my estimation of their competence has fallen.
On the other hand, here’s an article about a UK laboratory infecting people with a non-covid coronavirus to help with vaccine research.
But the space of possible vaccines is very large, I assume. So even with a ton of human testing that only takes three weeks, maybe this still doesn’t help much?
In principle, with enough resources, multiple vaccines could be tested this way in parallel. Not that there are that many vaccine candidates to try, as far as I know; but if there were some software that bulk-generated candidate molecules, it could be done, in principle. The limiting input is mobilized resources, not time.
Yeah, if you could reduce the space of possible vaccines to a smaller set of plausible ones, that certainly makes sense.
This makes me wonder, why not just let people volunteer to test risky treatments in general? Because there’d be bad actors who try weird shit willy nilly and misrepresent it to people as more plausible than it really is, such that the harm done to people outweighs the advancements in knowledge? But what if you remove the profit motive and only give this power to government researchers? Would they have too many career-y incentives to be too aggressive?
Human trials are much more expensive then trials in mice. If you can already rule out a drug by giving it to mice you save a lot of money that you don’t have to invest into your trial with humans.
Speed is not an important variable for government researchers outside of a situation like this where you need a fast response to a pandemic.
Speed matters a bit more for big pharma where it matters if you have one additional year of patent protection for your drug if you develop a year faster but even there the cost tradeoffs are in favor of doing animal testing.
It seems to me much more likely that the Chinese are doing human trials that skip animal testing then that the US intelligence community does that.
Terminally ill patients don’t make good subjects for clinical trials. If you run such a project outside of the reach of the FDA, it seems like a slight against the FDA. It’s not a step in which companies that produce vaccines and that want to have good relationships with the FDA want to make.
On the other hand the Chinese government has plenty of people in their prisons that they consider expandable and willing to sacrifice for the greater good. They should also have less institutional resistance to it
The “terminally ill” bit was part of the (probably false) rumor that I heard. Preexisting illness definitely screws with the safety-testing aspect, but there are also illnesses don’t interfere with the efficacy testing. I agree that a competent agency uses healthy people for this if they could. If experimenting on healthy people wasn’t possible or worth it, one possibility would be to do an efficacy trial on unhealthy people and a safety study on animals in parallel.
I have the impression that you ignore the institutional issues that are at play. The intelligence community can’t simply deploy a vaccine on their own. They need buy in from the FDA.
Legally speak, yes they would. Practically speaking, however, the FDA has no enforcement power over secret programs in the intelligence community.
I think a lot of people are seriously overestimating the FDA’s actual power, and that’s causing pretty severe problems. Consider for example this tweet (and a long series like it) by the mayor of NYC, begging the FDA for approvals. While there is no legal precedent to refer to, it’s extremely implausible that the FDA could ever get or enforce a judgment of the city of New York for actions taken during a state of emergency, when the FDA itself caused that emergency with culpable negligence.
The FDA has no power to stop the intelligence community running tests on patients but they do have the power to declare the results of the tests as not being enough to prove the resulting vaccines safe.
Do you really think that you have a better idea of the institutional power of the various players then the mayor of NYC? The FDA has a lot of relationships that allow it to exert power that are distinct from direct legal tools.
In general vaccines are very easy to make. You grow the virus you want to vaccinate against, kill or weaken it, and inject it, often with an adjuvant. Viral illnesses that don’t have vaccines today are the exception where it turns out that doesn’t work and it’s more challenging. These difficult ones are what all vaccine research today is focused on, so people think making vaccines is hard.
It usually isn’t. Small pox, measles, mumps, rubella, chicken pox, and polio are all gone. Flu is 4 new viruses we make brand new vaccines for every year.
I heard a rumor of someone in the Bay area claiming to work in the intelligence community, to be terminally ill, and to have received an experimental COVID-19 vaccine. I think this rumor is false with respect to the specific person, but do note that “military officers with preexisting terminal illnesses who volunteer” is a group that may actually exist, and that at least one drug company claims to have shipped vaccines for a phase 1 trial on Feb 24.
This raises the question: if you’re well resourced, desperate, competent, and in possession of expendable military volunteers, how long does development for a vaccine actually take?
Given a candidate vaccine, you need to do three things: find out if confers immunity (and how much immunity), find out if it causes side effects severe enough to not be worth it, and scale up production.
All three of these can be done in parallel. If you have expendable volunteers, you don’t need to start with an animal model; you can just give them the vaccine, and see whether they suffer side effects. Testing efficacy can be done in parallel, with the same volunteers, and takes about three weeks—you give the vaccine, wait a week, expose to virus, then wait in quarantine for two weeks.
If you’re unlucky, this kills all the test subjects. If you’re average-lucky, your test subjects get COVID-19 and die at the same rate as people die of that. If you’re lucky, you have solid evidence of effectiveness and moderate evidence of safety. Not as much evidence of safety as you want, and certainly not up to the FDA’s traditional standards, but good enough that medical workers in affected areas would seriously consider it.
Maybe it’s optimistic, but in my model of the world, there are islands of competence within the intelligence community which do things like this. In most worlds, this project fails, and the public never hears about it. The President, on the other hand, does hear about it. He hears about many vaccine projects with different timelines and different chances of success, and they all blend together. He says on the news that a vaccine will be ready in several weeks, and everyone—the NIAID, the press, the public—mocks him for the mistake, because they don’t know about the secret trial. Or maybe he never heard of anything like that, and is just confused; this is not something we are likely to ever know.
Coronavirus could spread unabated, or it could be killed by quarantines, or it could spread but lose its lethality to a new treatment, or we could be surprised by an unprecedentedly fast vaccine. Let us retain our flexibility, and keep our prediction confidence intervals wide.
For me, that fits my model of what the US intelligence agencies used to do during the cold war times, and we have unclassified documents about proactive, unethical experimentation they did—like Operation Sea Spray and MK Ultra. I don’t know if the 2020 US intelligence community is up to the same task. I get the impression that capability and competence have fallen there, although it’s hard to know since so much is classified. But judging by the fact that we have had several elections disrupted by pretty predictable cyberattacks without visible countermeasures, my estimation of their competence has fallen.
On the other hand, here’s an article about a UK laboratory infecting people with a non-covid coronavirus to help with vaccine research.
But the space of possible vaccines is very large, I assume. So even with a ton of human testing that only takes three weeks, maybe this still doesn’t help much?
In principle, with enough resources, multiple vaccines could be tested this way in parallel. Not that there are that many vaccine candidates to try, as far as I know; but if there were some software that bulk-generated candidate molecules, it could be done, in principle. The limiting input is mobilized resources, not time.
We have the genome of the virus. All the surface proteins of the virus are candidate molecules.
Yeah, if you could reduce the space of possible vaccines to a smaller set of plausible ones, that certainly makes sense.
This makes me wonder, why not just let people volunteer to test risky treatments in general? Because there’d be bad actors who try weird shit willy nilly and misrepresent it to people as more plausible than it really is, such that the harm done to people outweighs the advancements in knowledge? But what if you remove the profit motive and only give this power to government researchers? Would they have too many career-y incentives to be too aggressive?
Human trials are much more expensive then trials in mice. If you can already rule out a drug by giving it to mice you save a lot of money that you don’t have to invest into your trial with humans.
True. The downside would be that animal testing is slower, which is I think why jimrandomh was proposing human testing.
Speed is not an important variable for government researchers outside of a situation like this where you need a fast response to a pandemic.
Speed matters a bit more for big pharma where it matters if you have one additional year of patent protection for your drug if you develop a year faster but even there the cost tradeoffs are in favor of doing animal testing.
It seems to me much more likely that the Chinese are doing human trials that skip animal testing then that the US intelligence community does that.
Terminally ill patients don’t make good subjects for clinical trials. If you run such a project outside of the reach of the FDA, it seems like a slight against the FDA. It’s not a step in which companies that produce vaccines and that want to have good relationships with the FDA want to make.
On the other hand the Chinese government has plenty of people in their prisons that they consider expandable and willing to sacrifice for the greater good. They should also have less institutional resistance to it
The “terminally ill” bit was part of the (probably false) rumor that I heard. Preexisting illness definitely screws with the safety-testing aspect, but there are also illnesses don’t interfere with the efficacy testing. I agree that a competent agency uses healthy people for this if they could. If experimenting on healthy people wasn’t possible or worth it, one possibility would be to do an efficacy trial on unhealthy people and a safety study on animals in parallel.
I have the impression that you ignore the institutional issues that are at play. The intelligence community can’t simply deploy a vaccine on their own. They need buy in from the FDA.
Legally speak, yes they would. Practically speaking, however, the FDA has no enforcement power over secret programs in the intelligence community.
I think a lot of people are seriously overestimating the FDA’s actual power, and that’s causing pretty severe problems. Consider for example this tweet (and a long series like it) by the mayor of NYC, begging the FDA for approvals. While there is no legal precedent to refer to, it’s extremely implausible that the FDA could ever get or enforce a judgment of the city of New York for actions taken during a state of emergency, when the FDA itself caused that emergency with culpable negligence.
The FDA has no power to stop the intelligence community running tests on patients but they do have the power to declare the results of the tests as not being enough to prove the resulting vaccines safe.
Do you really think that you have a better idea of the institutional power of the various players then the mayor of NYC? The FDA has a lot of relationships that allow it to exert power that are distinct from direct legal tools.
There are some articles today about people trying out a drug called remdesivir
https://www.washingtonpost.com/business/economy/the-best-hope-for-coronavirus-treatment-is-an-experimental-drug-that-fizzled-against-ebola/2020/03/10/8a9e8cd4-5fe8-11ea-b29b-9db42f7803a7_story.html
In general vaccines are very easy to make. You grow the virus you want to vaccinate against, kill or weaken it, and inject it, often with an adjuvant. Viral illnesses that don’t have vaccines today are the exception where it turns out that doesn’t work and it’s more challenging. These difficult ones are what all vaccine research today is focused on, so people think making vaccines is hard.
It usually isn’t. Small pox, measles, mumps, rubella, chicken pox, and polio are all gone. Flu is 4 new viruses we make brand new vaccines for every year.